We work with you to ensure proactive, continuing compliance and manage emerging issues to minimise disruption to your business.
Recent examples of our work include:
- Negotiating recalls with multiple agencies for a misformulated product.
- Negotiating continuing registration and subsequent renewal for a device in China after discovery of major faults in original registration.
- Support to orthopaedic manufacturer in response to adverse findings in the National Joint Registry.
- Filing of adverse event reports
- Upgrades to postmarket compliance processes